MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed total bilirubin (tbi) results obtained on three (3) patient samples on a dimension exl 200 integrated chemistry system.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer.The customer removed the tbi flex lot from the system after level 1 quality control (qc) recovered out-of-range on the event date.But the customer did not perform ¿fix inventory¿ to verify the presence of the reagent lot in the system inventory.The erroneous results were obtained during sample processing due to the reagent lot not being present in the system.According to the dimension exl operator's guide, the customer is required to use the ¿fix inventory¿ option to verify the reagents in the reagent inventory.The customer ran qc and patient samples using another reagent lot, which recovered acceptably.Siemens determined that the cause of the event is consistent with the operator not using the ¿fix inventory¿ option in the system software.A product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that erroneously depressed total bilirubin (tbi) results were obtained on three (3) patient samples on a dimension exl 200 integrated chemistry system.The erroneously depressed results were reported to the physician(s), and the results were questioned.The same samples were reprocessed using another reagent lot on the original dimension exl 200 integrated chemistry system.The reprocessed results recovered higher than the erroneously depressed results and were considered correct.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed total bilirubin (tbi) results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TOTAL BILIRUBIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21863569
• Report Number: 2517506-2025-00064
• Device Sequence Number: 4592100
• Product Code: CIG
• UDI-Device Identifier: 00842768020544
• UDI-Public: (01)00842768020544(10)BA5208(17)250727
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2025
• Device Model Number: N/A
• Device Catalogue Number: DF167 SMN 10444957
• Device Lot Number: BA5208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown